Trial Outcomes & Findings for SlimShape Device for Abdominal Fat and Circumference Reduction (NCT NCT02999763)

Last Updated: 2019-04-18

Results Overview

Abdominal fat change, measured by ultrasound, post SlimShape treatments at 12 weeks follow-up (12wk FU) compared to baseline

Recruitment status

COMPLETED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

Baseline and 12 weeks follow-up

Results posted on

2019-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Treated and Untreated Abdomen Circumference and fat thickness reduction of abdomen after SlimShape treatments (three treatments with SlimShape RF based device)
Overall Study STARTED	70
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SlimShape Device for Abdominal Fat and Circumference Reduction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treated and Untreated Abdomen n=70 Participants Circumference and fat thickness measurements of abdomen before after SlimShape treatments of the same subjects
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	46 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	61 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	70 participants n=5 Participants
Fat Thickness	22.83 millimeter STANDARD_DEVIATION 7.22 • n=5 Participants
Circumference	91.64 centimeter STANDARD_DEVIATION 7.82 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks follow-up

Population: 58 participants analyzed at 12 week FU (12 subjects lost to follow-up at final visit)

Abdominal fat change, measured by ultrasound, post SlimShape treatments at 12 weeks follow-up (12wk FU) compared to baseline

Outcome measures

Outcome measures
Measure	Treated Abdomen n=58 Participants Subjects treated on the abdomen with SlimShape RF treatments
Change in Fat Thickness at Final Follow-up Compared to Baseline	-1.76 millimeters Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline and 4 and 8 weeks follow-up

Population: 63 participants attended the 4 week FU (5 dropped and 2 missed the visit), 59 participants attended the 8 week FU (10 dropped and 1 missed the visit)

Abdominal fat change, measured by ultrasound, post SlimShape treatments at 4 and 8 weeks follow-up after final treatment compared to baseline

Outcome measures

Outcome measures
Measure	Treated Abdomen n=70 Participants Subjects treated on the abdomen with SlimShape RF treatments
Change in Fat Thickness After Treatments Compared to Baseline Fat thickness change at 4 week FU	-0.51 millimeters Standard Deviation 2.2
Change in Fat Thickness After Treatments Compared to Baseline Fat thickness change at 8 week FU	-1.33 millimeters Standard Deviation 2.3

SECONDARY outcome

Timeframe: At 4 weeks, 8 weeks and 12 weeks follow-up (post last treatment)

Population: 63 participants attended the 4 week FU (5 dropped and 2 missed the visit), 59 participants attended the 8 week FU (10 dropped and 1 missed the visit), 58 participants attended the 12 week FU (12 Subjects dropped)

Change in abdominal circumference, measured by calibrated measuring tape, at 4, 8 and 12 weeks follow-up (after final treatment) compared to baseline

Outcome measures

Outcome measures
Measure	Treated Abdomen n=70 Participants Subjects treated on the abdomen with SlimShape RF treatments
Change in Abdominal Circumference After Treatments Compared to Baseline Abdominal circumference change at 8 week FU	-0.53 centimeter Standard Deviation 2.6
Change in Abdominal Circumference After Treatments Compared to Baseline Abdominal circumference change at 4 week FU	-0.53 centimeter Standard Deviation 2.6
Change in Abdominal Circumference After Treatments Compared to Baseline Abdominal circumference change at 12 week FU	-0.78 centimeter Standard Deviation 2.7

OTHER_PRE_SPECIFIED outcome

Timeframe: First, second and third treatments, Weeks 0 to 4

Population: 70 participants attended the first treatment, 67 participants attended the second treatment (2 dropped and 1 missed treatment) and 65 participants attended the third treatment (3 dropped and 2 missed treatment), therefore overall 202 treatments conducted during the study.

Discomfort and immediate response will be assessed immediately after each treatment using the Post Treatment Immediate Response severity scale (Absent/none, Mild, Moderate and Severe). The values in the data table reflect the number of participants who had discomfort during treatment or immediate response after treatment (reported as having "Mild", "Moderate" or "Severe" )

Outcome measures

Outcome measures
Measure	Treated Abdomen n=202 Overall Treatments Subjects treated on the abdomen with SlimShape RF treatments
Number of Treatments Where Participants Reported Having "Mild", "Moderate" or "Severe" Response The rate of erythema after treatment	199 Overall Treatments
Number of Treatments Where Participants Reported Having "Mild", "Moderate" or "Severe" Response The rate of edema after treatment	84 Overall Treatments
Number of Treatments Where Participants Reported Having "Mild", "Moderate" or "Severe" Response The rate of hematoma / purpura after treatment	11 Overall Treatments
Number of Treatments Where Participants Reported Having "Mild", "Moderate" or "Severe" Response The rate of petechiae after treatment	35 Overall Treatments
Number of Treatments Where Participants Reported Having "Mild", "Moderate" or "Severe" Response The rate of pain after treatment	19 Overall Treatments

Adverse Events

Treated Abdomen

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treated Abdomen n=70 participants at risk Subjects treated on the abdomen with SlimShape RF treatments
Skin and subcutaneous tissue disorders Blisters	10.0% 7/70 • Number of events 7 • Subjects were assessed and followed up for adverse events at each treatment (3 treatment at 2 weeks interval) and at 4 weeks, 8 weeks and 12 weeks after the SlimShape treatment
Skin and subcutaneous tissue disorders Vesicles	1.4% 1/70 • Number of events 2 • Subjects were assessed and followed up for adverse events at each treatment (3 treatment at 2 weeks interval) and at 4 weeks, 8 weeks and 12 weeks after the SlimShape treatment
Skin and subcutaneous tissue disorders Discoloration	1.4% 1/70 • Number of events 1 • Subjects were assessed and followed up for adverse events at each treatment (3 treatment at 2 weeks interval) and at 4 weeks, 8 weeks and 12 weeks after the SlimShape treatment
Skin and subcutaneous tissue disorders firm mass	1.4% 1/70 • Number of events 1 • Subjects were assessed and followed up for adverse events at each treatment (3 treatment at 2 weeks interval) and at 4 weeks, 8 weeks and 12 weeks after the SlimShape treatment

Additional Information

Director of Clinical Affairs

Syneron Medical

Phone: +972-73-2442347

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place